Communication on Progress of New Base Construction
Author：汉德编辑 Time：2019-04-28 10:56 Click：
1. Natural Paclitaxel Manufacture Line: three validation batches, each batch is 800g, had been finished total manufacture in 20th April, 2019. Inspection and stability testing is in progress. Test of Bacterial Endotoxins, Heavy Metal Elements and CP Related Substances is in progress till now. Estimated finishing whole items inspection around 20th May. Presently, we could provide samples according to requirement of clients for method validation of preparation or medical instruments. After total inspection of three validation batches, production supply to laboratory test and pilot test could be achieved. Client audit also could be accepted according to needs.
2. 10-DAB III Initial Processing Line: entered normal production. Capacity (per month): final product for 11-12 kg; half-finished product for 30 kg. 2 kg final product had been output and finished inspection. Output and inspection of 11 kg final product (effective content: 99%) and 40 kg half-finished product (effective content: 80%) would be finished in middle of May.
3.Separation experiment between paclitaxel and 10-DAT and process determination, preliminary trial of paclitaxel based on New Process for Natural Paclitaxel APIs are in progress.